Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial.
Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial.
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DOI：
10.1001/jama.2014.6490
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发表时间：
2014-07-02
影响因子：
120.7
通讯作者：
Tilley, Barbara C.
中科院分区：
文献类型：
--
作者：
Robertson, Claudia S.;Hannay, H. Julia;Yamal, Jose-Miguel;Gopinath, Shankar;Goodman, J. Clay;Tilley, Barbara C.
关于促红细胞生成素或高输血阈值在创伤性脑损伤（TBI）中的作用的信息有限。比较促红细胞生成素和两种输血阈值（7和10 g/dl）对脑外伤后神经系统恢复的影响。使用析因设计的随机试验来检验：1)促红细胞生成素是否不能使有利结果提高20%，2)输血阈值为100 ~ 10 g/dl是否能在不增加并发症的情况下增加有利结果。2006年5月至2012年8月，在两家休斯顿一级创伤中心的神经外科重症监护病房中，200例闭合性头部损伤患者在受伤后6小时内无法遵循指令；102例患者接受促红细胞生成素治疗，98例接受安慰剂治疗。促红细胞生成素或安慰剂最初每天服用3天，然后每周服用2周（n=74），然后在剩余的24小时和48小时剂量中减少（n=126）。99名和101名患者被分配到7g/dl和10g/dl输血阈值。静脉注射促红细胞生成素500 IU/kg或生理盐水。充血红细胞输血维持输血阈值。格拉斯哥结果量表在损伤后6个月分为有利（良好恢复和中度残疾）和不利（严重残疾，植物人或死亡）。红细胞生成素与输血阈值无相互作用。与安慰剂相比（良好转归率：34/89 [38.2%];95%CI=28.2-49.1%），两个促红细胞生成素组均无效（第一次给药方案：17/35 [48.6%];95%CI=31.4-66.0%, p=0.13；第二次给药方案：17/57 [29.8%];95%CI=18.4-43.4%, p<0.001）。7和10 g/dl阈值组的良好转归率分别为37/87（42.5%）和31/94 (33.0%)（95%CI差异= - 0.05 ~ 0.25,p=0.28）。10 g/dl阈值组血栓栓塞事件发生率较高（22/101 [21.8%]vs. 8/99 [8.1%], p=0.009）。在闭合性颅脑损伤患者中，给予促红细胞生成素或维持血红蛋白浓度bbb10 g/dl均不能改善6个月时的神经预后，且10 g/dl阈值与较高的不良事件发生率相关。在这种情况下，这些发现不支持任何一种方法。
There is limited information about the effect of erythropoietin or a high transfusion threshold in traumatic brain injury (TBI). To compare the effects of erythropoietin and two transfusion thresholds (7 and 10 g/dl) on neurological recovery after TBI. Randomized trial using a factorial design to test: i.) whether erythropoietin would fail to improve favorable outcomes by 20%, and ii.) whether a transfusion threshold of >10 g/dl would increase favorable outcomes without increasing complications. Neurosurgical intensive care units of two Houston level 1 trauma centers Between May 2006 and August 2012, 200 patients with closed head injury who were unable to follow commands were enrolled within 6 hours of injury; 102 patients received erythropoetin and 98 received placebo. Erythropoetin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (n=74) and then the 24h and 48h doses were dropped for the remainder (n=126). Ninety-nine and 101 patients were assigned to the 7g/dl and 10g/dl transfusion thresholds. Intravenous erythropoietin 500 IU/kg or saline per dose. Transfusion threshold maintained with packed red blood cell transfusion. Glasgow Outcome Scale dichotomized as favorable (good recovery and moderate disability) and unfavorable (severe disability, vegetative, or dead) at 6 months post-injury. There was no erythropoeitin-transfusion threshold interaction. Compared to placebo (favorable outcome rate: 34/89 [38.2%]; 95%CI=28.2-49.1%), both erythropoetin groups were futile (first dosing regimen: 17/35 [48.6%]; 95%CI=31.4-66.0%, p=0.13, and second dosing regimen: 17/57 [29.8%]; 95%CI=18.4-43.4%, p<0.001). Favorable outcome rates were 37/87 (42.5%) and 31/94 (33.0%) in the 7 and 10 g/dl threshold groups (95%CI for the difference = − 0.05 to 0.25, p=0.28). There was a higher incidence of thromboembolic events in the 10 g/dl threshold group (22/101 [21.8%] vs. 8/99 [8.1%], p=0.009). In patients with closed head injury, neither the administration of erythropoietin nor maintaining hemoglobin concentration > 10 g/dl resulted in improved neurological outcome at 6 months and the 10 g/dl threshold was associated with a higher incidence of adverse events.. These findings do not support either approach in this setting.
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影响因子：
15.8
作者：
Steyerberg EW;Mushkudiani N;Perel P;Butcher I;Lu J;McHugh GS;Murray GD;Marmarou A;Roberts I;Habbema JD;Maas AI
通讯作者：
Maas AI
影响因子：
4.1
作者：
Meng Y;Xiong Y;Mahmood A;Zhang Y;Qu C;Chopp M
通讯作者：
Chopp M
影响因子：
120.7
作者：
Hajjar, Ludhmila A.;Vincent, Jean-Louis;Auler, Jose O. C., Jr.
通讯作者：
Auler, Jose O. C., Jr.
DOI：
10.1097/00005373-197403000-00001
发表时间：
1974-01-01
影响因子：
--
作者：
BAKER, SP;ONEILL, B;LONG, WB
通讯作者：
LONG, WB
影响因子：
4.8
作者：
Maas, AIR;Hukkelhoven, CWPM;Steyerberg, EW
通讯作者：
Steyerberg, EW